MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Model Number	PNML6F088904M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the neuron max up the aortic arch, the proximal hub of the neuron max broke; therefore, the neuron max was removed.The procedure was completed using a new neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned neuron max was fractured at approximately 3.0 cm from the hub.The device was ovalized near its distal tip, approximately 90.0 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed a proximal fracture.If the neuron max was forcefully manipulated during use, damage such as this may occur.Further evaluation of the neuron max revealed an ovalization near its distal tip.This damage was likely incidental to the complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9826563
• Report Number: 3005168196-2020-00351
• Device Sequence Number: 1367498
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F89495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005